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Completed

NCT Number: NCT02700997

Uterosacral Ligament Suspension Clip

This study seeks to gain a more thorough understanding of the postoperative location of the sutures placed during uterosacral ligament suspension. Characterization of the surrounding anatomy in a living model will enhance surgical technique by delineating safer suture locations and decrease the incidence of morbid complications for patients.

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Key information

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

About this study

Uterosacral ligament suspension Is a commonly performed procedure to support the vaginal apex at the time of pelvic reconstructive surgery for pelvic organ prolapse (POP). Despite being a well established durable option for patients, there is little research detailing ligament suspension suture location in the living model. The available literature is limited to cadaveric studies, which suggest suture placement is in close proximity to vital structures such as the ureter, blood vessels, rectum and nerves.

This study seeks to describe suture location in relation to the surrounding anatomy in postoperative patients following high uterosacral ligament suspension. The secondary aim is to determine safe zones for suture placement.

Seventeen women (aged 18-85) under the care of Cincinnati Urogynecology Associates, a physician group of TriHealth, who have chosen vaginal hysterectomy with uterosacral ligament suspension (USLS) as the treatment choice for pelvic organ prolapse (POP) will be enrolled.

At the time of surgery, a titanium vascular clip (size small) will be applied to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging.

On postoperative day (POD) 1, patients will undergo CT pelvis scans. The CT scan will involve administration of IV contrast for imaging of the ureters and vascular structures. The clip will fall off when the sutures dissolve at 12 weeks postoperatively. All patients will be asked to complete a lower extremity neurological questionnaire preoperatively and postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women aged 18-85 with pelvic organ prolapse (POP) who have elected uterosacral ligament suspension (USLS) for treatment

Exclusion criteria

  • contraindication to computed tomography (CT), or intravenous (IV) contrast
  • those with claustrophobia
  • previous POP surgery
  • previous pelvic surgery to the fallopian tubes, ovaries, or rectum
  • previous pelvic radiation
  • known pelvic inflammatory disease or endometriosis
  • those with preexisting ureteral or vascular pathology or sacral anatomic abnormality
  • those with connective tissue disorders
  • those with preexisting neuropathy, chronic lower extremity pain disorders, or neurological disorders
  • those with renal anomalies such as pelvic kidney, duplication of the collecting system, prior nephrectomy
  • those with allergy to titanium
  • removal of the uterosacral sutures due to ureteral obstruction intraoperatively

Treatment and study plan

Vascular Clip

Device

Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging

Other names: Clip

Primary outcomes

  1. Suture Location in Relation to the Surrounding Anatomy

    Time frame: 1 day after surgery

    Measurement between internal iliac complex and proximal suture; measurement between ureter and proximal/distal suture.

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Uterosacral Ligament Suspension: A Radiographic Study of Anatomy and Suture Location

Acronym: USLS

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 7, 2016
Registry last updated
Nov 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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